Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF

Official Title ICMJE

Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease

Brief Summary

The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Detailed Description

Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.

The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.

Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;

Radiographic signs of subluxation greater than 3.5 mm;

Angulation of the disc space more than 11 degrees greater than adjacent segments;

Significant kyphotic deformity or significant reversal of lordosis;

Axial neck pain as the solitary symptom;

Previous cervical spine surgery;

Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.5. If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.

Active systemic infection or infection at the operative site;

Known allergy or to titanium, polyurethane, or ethylene oxide residuals;